FDA

Go or no go? Roche’s fresh start for a new year
EP Vantage
Mon, 12/20/21 - 10:59 am
FDA
Roche
Novartis
Pfizer
AstraZeneca
Cibinqo
Lynparza
Tezspire
Vyvgart
faricimab
bluebird bio Announces Partial Clinical Hold for Patients Under 18 in Sickle Cell Gene Therapy Clinical Program
Yahoo Finance
Mon, 12/20/21 - 10:54 am
Bluebird Bio
lovo-cel
gene therapy
sickle cell disease
FDA
clinical hold
clinical trials
What to Make of the FDA's Latest Warning to AbbVie and Pfizer
Motley Fool
Sat, 12/18/21 - 10:56 pm
FDA
AbbVie
Pfizer
Rinvoq
Xeljanz
JAK inhibitors
FDA removes in-person dispensing requirement for abortion medication
RAPS.org
Sat, 12/18/21 - 10:51 pm
FDA
REMS
abortion pill
FDA delays its decision on Bristol Myers' $13B heart drug another three months
Endpoints
Fri, 12/17/21 - 11:18 am
Bristol Myers Squibb
mavacamten
ICER
FDA
Citing blood clot risks, CDC advisers recommend mRNA pandemic vaccines over J&J shot
Fierce Pharma
Fri, 12/17/21 - 12:02 am
JNJ
vaccines
COVID-19
blood clots
FDA
MRNA
Pfizer files for full FDA approval of COVID-19 vaccine in adolescents
Yahoo/Reuters
Thu, 12/16/21 - 11:56 pm
Pfizer
BioNTech
COVID-19
FDA
adolescents
Biogen hits the gas pedal on Aduhelm confirmatory trial, hoping to deliver results in 2026
Fierce Pharma
Thu, 12/16/21 - 12:09 pm
Biogen
Aduhelm
FDA
clinical trials
Alzheimer's disease
Medtronic hit with FDA warning letter for diabetes devices
MedCity News
Thu, 12/16/21 - 11:20 am
devices
Medtech
Medtronic
diabetes
insuline pumps
FDA
MiniMed 600
Bristol Myers drug wins first U.S. approval for Graft versus Host Disease prevention
Reuters
Wed, 12/15/21 - 11:54 pm
Bristol Myers Squibb
Orencia
FDA
graft vs host disease
Amid safety concerns, FDA grants two new JAK approvals — but with added warnings and a key label change
Endpoints
Wed, 12/15/21 - 10:52 am
Pfizer
AbbVie
Xeljanz
Rinvoq
FDA
JAK inhibitors
FDA sets April date for verdict on Incyte’s vitiligo drug
Pharmaforum
Wed, 12/15/21 - 10:43 am
Incyte
Opzelura
vitiligo
FDA
Califf sails through confirmation hearing for FDA job, despite tensions over opioids
Stat
Tue, 12/14/21 - 11:31 pm
Robert Califf
FDA
Philips gets FDA clearance for two acute patient monitors
MedCity News
Tue, 12/14/21 - 10:58 am
Philips
devices
patient monitoring
Medtech
FDA
MX750
MX850
Novavax Stock Jumps As Drugmaker Looks to FDA Filing For Covid Vaccine By Year End
TheStreet.com
Mon, 12/13/21 - 10:39 am
Novavax
vaccines
COVID-19
FDA
UAE
Emergency Use Authorization
Why an FDA Panel Had Concerns About Merck's COVID-19 Pill
Motley Fool
Sat, 12/11/21 - 09:26 pm
Merck
COVID-19
FDA
molnupiravir
FDA expands authorization for Pfizer’s Covid-19 booster to cover 16- and 17-year-olds
Stat
Fri, 12/10/21 - 12:04 am
FDA
Pfizer
BioNTech
COVID-19
boosters
vaccines
adolescents
FDA adcomm votes unanimously against Reata's potential Alport syndrome treatment
Endpoints
Wed, 12/8/21 - 11:41 pm
FDA
Reata Pharmaceuticals
Alport syndrome
AstraZeneca's COVID therapy becomes first antibody approved for immunocompromised people preexposure
Fierce Pharma
Wed, 12/8/21 - 11:35 pm
AstraZeneca
COVID-19
antibodies
FDA
Emergency Use Authorization
Cancer treatments lead latest FDA breakthrough device designations
Medtech Dive
Wed, 12/8/21 - 10:45 am
Medtech
devices
FDA
breathrough devices
Reflexion Medical
Zetagen Therapeutics

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